A variety of dietary and drug regimens have been suggested for alleviating or preventing duodenal ulcers. These include special diets and drugs for alleviating pain and other symptoms.
In the present invention, non-absorbable, non-digestible polyesters of sugars (or sugar alcohols) are used as fat substitutes in foods and, conveniently, in unit dose forms as therapeutic compositions. The polyesters herein are fat-like in their physical properties and are excellent fat substitutes for use in low-calorie foods and diets.
The polyesters herein can be used in combination with fat-soluble vitamins so as to supply the body's requirement therefor. The polyesters herein interfere with the body's absorption of cholesterol and thereby provide a means for treating hypercholesterolemia, as well as ulcer treatment. The polyesters can potentially interfere with the body's absorption of fat-soluble vitamins, but this problem is overcome by fortification with vitamins. It has also been determined that some liquid polyesters can also cause an undesired anal leakage effect. This can be corrected by choosing polyesters of the preferred rheology or by adding certain agents to the polyester/vitamin compositions to avoid this undesired effect. (See U.S. Pat. Nos. 4,005,196 and 4,005,195.)
The following references are relevant to the present invention.
U.S. Pat. No. 3,600,186 (1971) to Mattson and Volpenhein discloses low-calorie food compositions containing polyol polyesters of the general type employed herein, and their use in combination with hardstocks which are fatty acid sources.
U.S. Pat. No. 3,954,976 of Mattson and Volpenhein, entitled "Pharmaceutical Compositions for Inhibiting Absorption of Cholesterol," discloses and claims sugar polyesters of the general type employed herein for the treatment and/or prevention of hypercholesterolemia. A variety of optional carriers are mentioned, including the fatty acid, stearic acid.
U.S. Pat. No. 1,656,474 (1928) to Dubin discloses edible fat compositions consisting of ethyl and glycerol esters of odd-chain fatty acids in combination with fat-soluble vitamins.
Mattson and Nole, The Journal of Nutrition, Vol 102, No. 9, Sept. 1972, at pages 1171-1175, report on the lack of absorbability of sugar polyesters of the general type employed herein in rats. The rats were fed water-soluble vitamins in the diet and given one drop of fat-soluble vitamins per week.
U.S. Pat. No. 2,962,419 (1960) to Minich relates to neopentyl fatty esters, their use as fat substitutes, and their use with "vitamins", among other things.
U.S. Pat. No. 3,160,565 (1964) to H. E. Duell relates to sugar mono-, di- and tri-esters and their use as carriers for various orally administered medicinals, including the B vitamins.
U.S. Pat. No. 3,849,554 (1974) to Winitz discloses means for reducing blood serum cholesterol by ingesting diets comprising a fatty acid source, said diets being low in sucrose.
U.S. Pat. No. 2,893,990 (1959) to Hass, et al., discloses fatty acid mono- and di-esters of sucrose which aid in the absorption of fat from the digestive tract.
U.S. Pat. No. 3,158,490 (1964) to Baur and Lutton discloses non-cloudy salad oils containing esters of disaccharides in which there are not more than five unesterified hydroxyl groups. See also U.S. Pat. Nos. 3,059,009 (1962) and 3,059,010 (1962) to Schmid and Baur.
U.S. Pat. No. 2,997,492 (1961) to Martin is directed to a method of making partial fatty acid esters of hexitols. U.S. Pat. No. 2,997,491 (1961) to Huber is directed to the synthesis of partial fatty esters of inositol. The general methods of synthesis disclosed in these patents can be used to prepare the liquid polyesters herein. Preferred methods of synthesis are fully disclosed hereinafter.